Role of Kabasura Kudineer in managing Covid patients

Phase 3

Completed

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2021/04/032952

Lead Sponsor: Sri Sri tatva advanced research institute

Brief Summary: Eligible patients will be invited to participate in the study. They will be provided with the details of clinical trial and their willingness to participate in study. Participants will be informed that they are ready to withdraw anytime from the trial. Computer generated stratified randomization code ( strata: asymptomatic , mild , moderate) will be prepared and allocation in two study arms will be done using sequentially numbered opaque envelopes by dept clerk not involved in study. Each participants will be examined with detailed history, general and systemic examination. Baseline laboratory investigation i.e cbc, rbs, thyroid profile, LFT and RFT will be carried. However treatment will be started before the results of test are available. If any abnormality detected in baseline investigations then participant will be removed from the study and reason will be noted. If in intervention arm then Kabasura kudineer will be stopped and will be offered to take the allopathy treatment as per standard protocol. If in control arm then will continue to take the allopathy drug. Replacement of this participants will be done till required 50 is selected in each group. Case proforma will be filled accordingly.

**Study arms**

**For asymptomatic and mild cases**

Arm 1 - trial group- Kabasura kudineer tablet formulation

Arm 2 - control group â€“ only allopathic medicines as per standard protocol by goi i.e Tab vitamin c oral once a day for 15 days and Paracetamol 500 mg sos not more than 4 tabs a day, cetrizine 10 mg od for 5 days, cough syrup 5-10 ml bd for 5 days etc

**For Moderate cases**

Arm 1 - trial group- Kabasura kudineer tablet formulation with standard allopathy as per GOI and institutional protocol

Arm 2 - control group standard allopathy as per GOI and institutional protocol

**Details of intervention**

Kabasura kudineer: Participants in this arm will receive ayush formulation Kabasura kudineer tablet which is classical siddha formulation that licenced with no. Aus 782, licensing authority : Dept of Ayush, Karnataka. Two tab will be given thrice a day after food for period of 15 days . Participants will be advised to be take medicine only after food.

Standard treatment

Asymptomatic : Home isolation, tab Vitamin C, Maintain hydration, Symptom monitoring

Mild case: Home isolation , Vitamin C + symptomatic treatment , Maintain hydration,Symptom monitoring

Moderate case : Hospitalize and treat as per protocol

**Follow Up, monitoring of symptoms and complaince to treatment**:

Participants will be followed on day 5,10, 15 and 21-28 either physically in OPD or by telephone irrespective of presence or absence of symptom. Atleast 2 visits is must for each participants. PRIEST scorewill be calculated during each visit. Daily monitoring of symptoms and Compliance with treatment will be assessed telephonically and counsel to complete the treatment . Those who are non complaint for more than 3 occasions will be noted as non complaint and reason for non complaince will be noted. They will be informed on importance of isolation, Covid care and monitoring the symptom of their family memebers. Participants will be told to visit hospital in case of any aggravation of symptom or developing new symptoms. They will be treated according to std protocol.

**Participants withdrawal criteria**

1.Participants are free to withdraw from trial at any point of time (reason for withdrawal will be noted in CRF)

2. If any adverse reaction or side effect during the study. Decision will be taken after through investigation by researchers. Reason will be noted and informed to institutional ethics committee and sponsor within 24 hours. Participant will be treated as per standard protocol of hospital.

**Statistical Methods**

Baseline characteristic of both the group will be reported in terms of proportion/ Mean (SD) and difference at baseline will be assessed by chi square or t test respectively. Intention to treat analysis will be applied. Categorical pre and post variables of each group and between the group will be analysed using chi square. Continuous variables will be analyzed depending on distribution of data by parametric or non-parametric statistics. Post hoc power analysis will be carried out to assess the power of study.

**Stopping the trail**

If one adverse event / death is found to be associated with intervention drug after doing casualty assessment and submitting the report to IEC , then drug trail will be stopped.

**Ethics Clearance:**

Ethical permission from IEC, AIIMS Rishikesh will be taken before the start of study. Study will be registered with CTRI. Helsinki Declaration, ICH-GCP Guidelines and ethical guidelines of ICMR, New Delhi will strictly adhered.

**Privacy and Confidentiality**

Privacy and confidentiality of data of participants will be strictly maintained. Personal identity of participants will never be revealed and will be coded. Data will be kept in secured locked cabinet and soft copy with password locked. This will not be shared with those outside research team. Identity of participants will not be revealed in any meeting or publication or conference . Data will be stored for period of 5 years.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

Age between 18 to 55 years, both male & female Asymptomatic, mild to moderate confirmed cases of covid19 infection as per GOI definition Reported to OPD within 3 days of onset of symptoms Willing to take ayush treatment.

Exclusion Criteria

patients not willing to give consent or participate in the clinical trial patients with co-morbidities like known case of hypertension , diabetes, heart diseases thyroid disorders,liver or renal diseases,moderate to severe anemia, blood related disorders etc Patients with associated co-morbidities like known case of hypertension, type 2 or type 1 diabetes or chronic or acute renal failure, thyroid disorder, respiratory diseases (asthama, copd ) renal diseases.
Baseline investigation CBC, LFT, KFT, RBS shows abnormalities patients on immuno-suppressive therapy pregnant women or lactating mothers undergone major surgery in recent 6 months or hospitalized for more than 3 days for any condition.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a.Time needed for improvement and relief in sign and symptoms individually and term of Pandemic Respiratory Infection Emergency System Triage (PRIEST) score	at baseline, 5 days, 10 days and 15 days , 21-28 days
b.Variation in immunity markers ( IL6, CRP)	at baseline, 5 days, 10 days and 15 days , 21-28 days
c.Time needed for sero-conversion	at baseline, 5 days, 10 days and 15 days , 21-28 days
d.Duration and events during hospital / home stay	at baseline, 5 days, 10 days and 15 days , 21-28 days
e.Time for clinical recovery in terms of rtpcr and viral clearance	at baseline, 5 days, 10 days and 15 days , 21-28 days

Secondary Outcome Measures

Name	Time	Method
a.Residual symptoms if any from 21 days to 3 months of follow up	b.Effect on mental health as measured by DASS 21 (hindi version open source)

Trial Locations

Locations (1): AIIMS Rishikesh
🇮🇳
Dehradun, UTTARANCHAL, India
AIIMS Rishikesh
🇮🇳Dehradun, UTTARANCHAL, India
Dr monica Pathania
Principal investigator
8126021556
anshupathania27@gmail.com